Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3012
In Commercial Distribution

  • 09348215080389 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3011
In Commercial Distribution

  • 09348215080372 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3010
In Commercial Distribution

  • 09348215080365 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3009
In Commercial Distribution

  • 09348215080358 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3008
In Commercial Distribution

  • 09348215080341 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2006
In Commercial Distribution

  • 09348215080150 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2005
In Commercial Distribution

  • 09348215080143 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2004
In Commercial Distribution

  • 09348215080136 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2003
In Commercial Distribution

  • 09348215080129 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2002
In Commercial Distribution

  • 09348215080112 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2001
In Commercial Distribution

  • 09348215080105 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6050
In Commercial Distribution

  • 09348215087340 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6040
In Commercial Distribution

  • 09348215087333 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6030
In Commercial Distribution

  • 09348215087326 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6020
In Commercial Distribution

  • 09348215087319 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6010
In Commercial Distribution

  • 09348215087302 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6000
In Commercial Distribution

  • 09348215087296 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5016
In Commercial Distribution

  • 09348215087449 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5015
In Commercial Distribution

  • 09348215087432 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5014
In Commercial Distribution

  • 09348215087425 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5013
In Commercial Distribution

  • 09348215087418 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-114
In Commercial Distribution

  • 09348215074777 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-116
In Commercial Distribution

  • 09348215074791 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution

  • 00850018836029 ()


  • Gait rehabilitation frame, electric
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds.
ARETECH, LLC
OV-700
In Commercial Distribution

  • 00850018836043 ()


  • Gait rehabilitation frame, electric
CURVED TAMP
SpineArt SA
SPE-US 01 42-N
In Commercial Distribution

  • 07640375236173 ()
SPE-US 01 42-N

  • Bone graft packing block
PLIF SG INSTRUMENTS CAGE FILLER BLOCK
DEPUY SPINE, LLC
273126001
Not in Commercial Distribution

  • 10705034186870 ()
273126001

  • Bone graft packing block
BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness
BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness
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